Senior Product Development Engineer

Company Description

Nyra Medical, located in Atlanta, Georgia, is a clinical-stage medical company dedicated to transforming structural heart care. The company’s mission is to enhance and extend the lives of patients with valvular heart disease through innovative transcatheter solutions. Nyra Medical’s proprietary technology, the Cardiac Leaflet Enhancer (CARLEN), is Nyra Medical’s investigational medical device, with proprietary transcatheter technology designed to repair functional (secondary) mitral regurgitation (FMR) by augmenting the native mitral valve — not restricting it. Unlike traditional transcatheter edge-to-edge repair (TEER) systems that approximate both leaflets and alter valve geometry, CARLEN is a single-leaflet implant designed to restore coaptation while preserving the valve’s natural motion and orifice area. CARLEN aims to broaden access to transcatheter repair for both TEER-eligible patients and those previously excluded by anatomical limitations. Capitalizing on existing workflow, the CARLEN System is delivered via a transfemoral, transseptal approach, enabling intuitive, precise leaflet enhancement without sutures, tethers, or permanent deformation.

Role Description

Atlanta-based on-site opportunity for a passionate, patient-focused Senior Product Development Engineer who is motivated to join an innovative company focused on advancing a novel transcatheter solution for patients suffering from mitral valve disease. This is a hands-on opportunity will allow the engineer to work closely as a part of the product development team to identify and execute design refinements of the CARLEN delivery system based on clinical feedback. The engineer will lead the delivery system team in delineating and performing testing to facilitate the implementation of delivery system refinements.

Qualifications

• Bachelors Degree in Mechanical or Biomedical Engineering (Advanced degree preferred).
• Minimum of 5 years of relevant experience on research and development teams in the medical device industry.
• Experience in the Structural Heart Space with a particular preference for Class III transcatheter project experience is preferred.
• Experience with startup companies is ideal, but not required.

Responsibilities

• Conceptualize and develop test equipment in response to specified design requirements.
• Refinement of implant/delivery system based on functional testing, mechanical testing, and/or simulated use.
• Collaborate with cross-functional team members and contract manufacturers.
• Brainstorm novel ideas for design improvements using testing results.
• Develop test methods for Design Verification testing, draft test procedures/reports, and support test method validations.
• Provide documentation support and complete written reports on testing and designs.
• Actively participate in design reviews and provide relevant feedback for teammates.
• Provide engineering leadership to drive the development activities to ensure on time regulatory submissions.
• Lead design and optimization of more complex experiments, tests, analyze results, provide recommendations, and develop reports, based on engineering principles that translate to innovative products.
• Proactively identify issues, achieve resolution, and resolve problems of significant complexity on designing parts, components and subsystems.
• Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications.
• Create/update complex design control documents including requirement specs, and risk documents.
• Develop project plans to assess technology and drive project results
• Ability to travel up to 50% of the time to manufacturing, device testing, and clinical testing locations in the US and OUS.
• Strong proficiency in design (experience in CAD, SolidWorks preferred)
• Experience in complex mechanical delivery system.
• Catheter design and testing experience.
• Class III implant design and testing experience